Senior Regulatory Affairs Manager, Italy

  • Permanent
  • Italy


Join a pioneering mid-size global pharmaceutical company, known for its dedication to improving the lives of patients with rare disease conditions. Our client is seeking a highly driven and enthusiastic Senior Regulatory Affairs Manager to lead regulatory affairs within their Italian affiliate based in Rome. This pivotal role bridges the gap between groundbreaking healthcare solutions and the people who need them most, offering the chance to significantly impact the Italian healthcare landscape. As part of the Italian Regulatory & Medical Team, this position embodies our core values of excellence, collaboration, and innovation.


Responsibilities & Requirements:

  • Craft and implement strategic scientific regulatory frameworks in collaboration with global teams, ensuring compliance with internal and external standards.
  • Evaluate new technologies with a focus on scientific and regulatory compliance, aiding in SOP development and ensuring global alignment
  • Coordinate with Local Quality Assurance and internal stakeholders to oversee quality activities, promoting a culture of high regulatory standards and scientific excellence.
  • Foster strong regulatory scientific networks within the company, supporting regulatory functions across various locations and ensuring adherence to pharmaceutical advertising regulations.
  • Provide AIFA (Italian Medicines Agency) with necessary information and support, ensuring all company activities comply with local health regulations and decrees.
  • Requires an advanced degree in science/medicine (MD, PhD, PharmD) with a few years of experience in the pharmaceutical/biotherapeutics industry
  • Previous experience in managing and mentoring team members is crucial for this leadership position


What You Get in Return:

  • A unique opportunity to make a real difference in patients’ lives within a role that blends scientific rigor with strategic regulatory oversight.
  • The chance to work within a collaborative and innovative environment, where your contributions are valued and encouraged.
  • A competitive salary and benefits package, including a comprehensive relocation package for moving to Rome
  • Continuous professional development opportunities in a company that champions growth, learning, and innovation.

If you possess the requisite skills and expertise for this role and are eager to enhance your career with a leading biopharmaceutical company committed to groundbreaking patient care, please reach out to Hafsa for more information or send your CV today.

Hafsa is a Senior Client Partner at Haybury Search covering Europe, UK, North America, and Asia.

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